3 min

Post-Market Surveillance: Key Considerations for Medical Device Compliance

Post-market surveillance (PMS) has undergone significant transformation under the Medical Device Regulation (MDR) in Europe. It marks a new era in the monitoring and reporting of medical device safety and performance. This set of requirements emphasizes the proactive collection and analysis of medical device-related data after a product is placed on the market, allowing manufacturers to reassess the safety and effectiveness of their medical devices continuously.

Understanding the MDR Requirements for PMS

The MDR outlines the PMS requirements in Chapter VII, Section 1, through a series of clear and concise articles. Manufacturers are mandated to establish a comprehensive post-market surveillance system, which involves developing a series of plans and reports based on guidance from various annexes. Many organizations, particularly those new to regulatory compliance and small to medium enterprises, often find it challenging to implement effective PMS strategies that comply with the MDR.

The Medical Device Coordination Group (MDCG) has released several valuable guidance documents that offer templates, definitions, and specific recommendations related to PMS. Although these documents are not legally binding, they are based on peer-reviewed and industry-accepted knowledge that can help clarify and simplify PMS requirements. Notably, the MDR emphasizes the MDCG's role in promoting harmonization in the implementation of these regulations.

Key MDCG Documents for Post-Market Surveillance

Several MDCG documents relevant to PMS include:

  • MDCG 2021-1 Rev. 1: Guidance on administrative practices and alternative technical solutions until EUDAMED is fully functional.
  • MDCG 2024-1: Device Specific Vigilance Guidance (DSVG) Template.
  • MDCG 2024-1-1 to 2024-1-5: Specific DSVGs for various medical devices (e.g., cardiac ablation, coronary stents, breast implants).
  • MDCG 2023-3: Questions and Answers on vigilance terms and concepts.
  • MDCG 2022-21: Guidance on the Periodic Safety Update Report (PSUR) according to Regulation (EU) 2017/745.

The Role of IMDRF in Post-Market Surveillance

One of the notable advancements in PMS is the integration of International Medical Device Regulators Forum (IMDRF) terminology. Although this terminology is applicable to various aspects of vigilance and PMS, many medical device organizations have yet to incorporate IMDRF into their PMS procedures or may be unfamiliar with its importance.

The IMDRF aims to facilitate global harmonization of medical device regulations, and its terminology is now part of the European post-market requirements. This terminology is already implemented in incident reporting through the Manufacturer Incident Report (MIR) and the PSUR (MDCG 2022-21). Manufacturers can access the IMDRF coding system through its official website, which provides both Excel and web-based formats, and they are encouraged to participate in available training sessions.

Specific IMDRF coding requirements exist for PMS and vigilance reporting. For instance, the MIR mandates the use of Level 3 coding for serious incidents, while the PSUR allows Level 2 coding for grouping incidents.

Data Presentation and Reporting Requirements

Another significant aspect of the new PMS framework is the requirement for manufacturers to present PMS data by region and globally, utilizing specific year-to-year monitoring periods. This is outlined in MDCG 2022-21, Annex III. Manufacturers distributing in multiple regions must report their distribution and incident data by region, defined as the EEA, Turkey, and Northern Ireland.

Furthermore, manufacturers need to organize their data to facilitate the retrieval and reporting of region-specific information. Incident reports require manufacturers to provide data from the current calendar year and previous years, while the PSUR specifies a monitoring period of one or two years, depending on medical device risk classification. It is essential to note that data prior to the MDR date of application is considered historical and must be indicated as such.

Implementing a post-market surveillance system can be challenging for many organizations. There is often a misconception that PMS merely involves meeting reporting requirements based on existing quality management system (QMS) data. In reality, PMS is a systematic, proactive process designed to collect and analyze specific data regarding medical devices on the market.

Effective PMS represents a continuous Plan-Do-Check-Act (PDCA) cycle, where the focus is not solely on planning and reporting but on proactive monitoring and evaluation. By observing, assessing, reporting, and ultimately ensuring the quality, performance, and safety of medical devices throughout their lifecycle, manufacturers can fulfill their regulatory obligations and safeguard public health.